Tissue retractor and guide device

ABSTRACT

A tissue retractor and guide device for use in securing a spinal fixation plate to a spine is provided. In general, the device includes an elongate member having a guide member formed thereon or mated thereto with at least one pathway for receiving a tool. The guide member is adapted to be juxtapositioned on a spinal implant, while the distal portion of the elongate member is effective to retract tissue disposed adjacent to the guide member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 10/609,123, filed on Jun. 27, 2003, entitled “Tissue Retractorand Drill Guide,” which is expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to devices for assisting in spinalsurgery, and more particularly to a tissue retractor and guide devicefor introducing spinal tools and devices.

BACKGROUND OF THE INVENTION

Advancing age, as well as injury, can lead to changes in the bones,discs, joints, and ligaments of the spine, producing pain from nerveroot compression. Under certain circumstances, alleviation of pain canbe provided by performing a spinal fusion. This is a procedure thatinvolves joining two or more adjacent vertebrae with a bone fixationdevice so that they no longer are able to move relative to each other.For a number of known reasons, bone fixation devices are useful forpromoting proper healing of injured or damaged vertebral bone segmentscaused by trauma, tumor growth, or degenerative disc disease. Theexternal fixation devices immobilize the injured bone segments to ensurethe proper growth of new osseous tissue between the damaged segments.These types of external bone fixation devices often include internalbracing and instrumentation to stabilize the spinal column to facilitatethe efficient healing of the damaged area without deformity orinstability, while minimizing any immobilization and post-operative careof the patient.

One such device is a bone fixation plate that is used to immobilizeadjacent skeletal parts such as bones. Typically, the fixation plate isa rigid metal or polymeric plate positioned to span bones or bonesegments that require immobilization with respect to one another. Theplate is fastened to the respective bones, usually with bone screws, sothat the plate remains in contact with the bones and fixes them in adesired position. Bone plates can be useful in providing the mechanicalsupport necessary to keep vertebral bodies in proper position and bridgea weakened or diseased area such as when a disc, vertebral body orfragment has been removed.

Such plates have been used to immobilize a variety of bones, includingvertebral bodies of the spine. These bone plate systems usually includea rigid bone plate having a plurality of screw openings. The openingsare either holes or slots for screw placement. The bone plate is placedagainst the damaged vertebral bodies and bone screws are used to securethe bone plate to the spine and optionally to a prosthetic implant orbone graft positioned between the adjacent vertebrae. Implantation ofthe plate, however, can be difficult. Each plate must be properlyaligned with the vertebral bodies, and holes for receiving the bonescrews must be drilled into the vertebrae at precise angles. It is oftennecessary to use the bone plate as a drill guide for drilling andtapping the bone in preparation for receiving the bone screws. Such aprocedure can be difficult, however, as the surgeon is required tosecurely and rigidly hold the bone plate against the vertebrae, obtainproper alignment, drill, tap, and finally set the bone screws.

The procedure may be further complicated by the need to retract tissuefrom the surrounding area. Retraction has traditionally requiredadditional tools and an extra step to pull tissue away from the workingarea prior to and during the procedure. The use of such additional toolscan hinder access to the site and can require a surgeon or an assistantto perform multiple tasks simultaneously. A retractor which is left inplace during the procedure can also cause stress to the surroundingtissue and may cause the patient additional discomfort and a prolongedrecuperation.

Accordingly, there remains a need for an instrument that can be used toperform multiple tasks during spinal surgery.

SUMMARY OF THE INVENTION

The present invention generally provides a tissue retractor and guidedevice having an elongate member with a distal portion that is adaptedto retract tissue, and a guide member that is coupled to the elongatemember and that includes at least one pathway formed therein forreceiving a tool. In use, the guide member is adapted to be positionedin relation to a spinal implant, and preferably to be juxtapositioned ona spinal implant such that the pathway is aligned with at least onecorresponding bore formed in the spinal implant to guide a tool throughthe bore.

The guide member can have a variety of configurations, shapes, andsizes, but in general the guide member includes at least one pathway,and more preferably two pathways, formed therein. The pathways can beseparate from one another, such that they are defined by lumensextending through a single housing or extending through two separatehousings, such as barrels, or alternatively they can be at leastpartially in communication with one another such that they are formedwithin a hollow housing. In an exemplary embodiment, the guide memberincludes front and back opposed sidewalls, opposed lateral sidewallsextending between the front and back sidewalls, and two pathways formedtherebetween. The back sidewall of the guide member is preferablycoupled to the elongate member.

In another embodiment, the guide member can include at least one cut-outportion formed therein and adapted to provide visual access to a spinalimplant coupled thereto. Preferably, a cut-out portion is formed in thefront sidewall between the two pathways, and it extends from theproximal end to the distal end of the guide member. As a result of thecut-out portion, the pathways are at least partially in communicationwith one another.

The guide member of the tissue retractor and guide device can alsooptionally include one or more alignment features formed thereon andadapted to align the guide member with a spinal implant. In an exemplaryembodiment, the alignment feature(s) is in the form of an extensionportion that extends distally from the guide member, and that ispreferably adapted to rest against a perimeter of a spinal implant toalign the guide member with the implant. More preferably, the alignmentfeature is in the form of first and second tabs that extend distallyfrom a distal-most end of the guide member. Each tab can vary in shapeand size, but each tab preferably has a substantially concave innersurface that is adapted to be positioned against a substantially concaveouter surface formed on a perimeter of a spinal implant. In anotherembodiment, the alignment feature can be in the form on an extensionportion that extends from the back sidewall of the guide member, or thatis formed on and extends distally from the distal portion of theelongate member. Preferably, a distal-most surface of the extensionportion is substantially concave to match the contour of a vertebralbody.

In another embodiment of the present invention, the tissue retractor andguide device can include at least one mating element formed thereon andadapted to mate with a corresponding mating element formed on a spinalimplant. The mating element is preferably formed on a distal end of theguide member, and it can be, for example, a pin, spike, groove, cleat,hole, hook, threaded hole, threaded pin, and combinations thereof. In anexemplary embodiment, the mating element has a shape that is adapted toprevent rotation between the guide member and a spinal implant when theguide member is juxtapositioned on the spinal implant.

In other aspects of the present invention, the guide member can includea first barrel having a lumen extending therethrough, and a secondbarrel having a lumen extending therethrough. The first and secondbarrels are preferably positioned at an angle with respect to oneanother, and more preferably the first and second barrels lie in a planethat is substantially parallel to at least a portion of a front surfaceof the distal portion of the elongate member. At least one of the firstand second barrels of the guide member has an adjustable trajectory suchthat the barrel can pivot about a point on a longitudinal axis thereof.The barrels can optionally be removably mated to the guide member.

The present invention also provides a tissue retractor and guide kitthat includes at least one tissue retractor and guide device that isadapted to couple to a spinal implant. The device has a guide memberwith opposed front and back sidewalls, opposed lateral sidewallsextending between the front and back sidewalls, and at least one pathwayformed therein receiving a tool. An elongate member is coupled to theback sidewall of the guide member and includes a proximal, handleportion, and a distal, tissue-retracting portion.

In one embodiment, the kit includes a cross member that is adapted toremovably connect two tissue retractor and guide devices. The crossmember can have a variety of configurations, and by way of non-limitingexample, it can be in the form of a substantially rectangular housing,or it can be in the form of an elongate rod having opposed ends, each ofwhich are adapted to removably mate to a tissue retractor and guidedevice.

In another embodiment, the kit includes a spinal fixation plate having asuperior portion with at least one bore formed therein for receiving afixation device effective to mate the superior portion to a firstvertebrae, and an inferior portion with at least one bore formed thereinfor receiving a fixation device effective to mate the inferior portionto a second, adjacent vertebrae. The guide device is adapted to bejuxtapositioned on the spinal fixation plate, preferably such that twopathways extending through the guide member align with two adjacentbores formed in at least one of the superior portion and the inferiorportion of the spinal fixation plate.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side perspective view of a tissue retractor and guide deviceaccording to one embodiment of the present invention;

FIG. 2 is a side view of the device shown in FIG. 1;

FIG. 3 is a top view of the device shown in FIG. 1;

FIG. 4 is an enlarged view of the distal portion of the device shown inFIG. 1;

FIG. 5A is an enlarged, front view of another embodiment of a guidemember for use with a device in accordance with the present invention;

FIG. 5B is an enlarged, back view of the guide member shown in FIG. 5A;

FIG. 6 is a side view of the tissue retractor and guide device of FIG. 1mated to one embodiment of a spinal fixation plate;

FIG. 7 is a perspective view of the device and the fixation plate shownin FIG. 6; and

FIG. 8 is a side view of two tissue retractor and guide devices mated toone another by a cross member, and mated to a spinal fixation plateaccording to another embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In general, the present invention provides a tissue retractor and guidedevice that is useful during spinal surgery to retract tissue, as wellas to facilitate implantation of a spinal implant, such as a spinalfixation plate. The device includes an elongate member having aproximal, handle portion, and a distal portion that is adapted toretract tissue disposed adjacent thereto. A guide member is coupled tothe distal portion of the elongate member, and it includes at least onepathway, and more preferably two pathways, extending therethrough forreceiving a tool. In use, the distal portion of the elongate member isadapted to retract tissue disposed adjacent to the guide member, and theguide member is adapted to be juxtapositioned on a spinal implant suchthat the pathway is aligned with a corresponding bore formed in thespinal implant. A tool can then be passed along the pathway and throughthe corresponding bore in the implant.

The tissue retractor and guide device of the present invention isparticularly advantageous in that it combines the functions of a tissueretractor and a guide devices, thereby allowing a surgeon to retracttissue surrounding a surgical site while simultaneously using the guidemember to introduce tools to facilitate implantation of a spinalimplant. The device further allows a relatively small incision to beused to access the surgical site since it eliminates the need foradditional tissue retraction tools. The device is also advantageous inthat it allows a surgeon to selectively retract tissue only as needed,rather than retracting tissue during the entire procedure, which cancause stress on the tissue.

A person skilled in the art will appreciate that, while the device isdescribed for use in connection with a spinal fixation plate, the tissueretractor and guide device can be used with a variety of implants for avariety of medical procedures. Moreover, the term “tool” as used hereinis intended to include a variety of devices and/or implants.

FIGS. 1-4 illustrate one embodiment of a tissue retractor and guidedevice 10 in accordance with the present invention. As shown, the device10 includes an elongate member 12 having a proximal, handle portion 14,and a distal portion 16 that is coupled to a guide device 30. Theelongate member 12 can have a variety of configurations, shapes andsizes, but it should be effective to retract tissue adjacent to theguide member 30 during use of the device 10. In an exemplary embodiment,the proximal portion 14 is adapted to extend out of a patient's body,and the distal portion 16 is effective to retract tissue. The proximaland distal portions 14, 16 can be fixedly attached to, removably matedto, or integrally formed with one another, but preferably the proximalportion 14 is disposed at an angle β with respect to the distal portion16, as shown in FIG. 1, to facilitate visual access to the surgicalsite. While the angle β between the proximal and distal portions 14, 16can vary, in an exemplary embodiment, the angle β is in the range ofabout 110° to 160°, and more preferably it is in the range of about 125°to 145°. Moreover, while only a single bend is shown between theproximal and distal portions 14, 16, a person skilled in the art willappreciate that the elongate member 12 can include two or more bends tofacilitate visual access to the surgical site and/or to facilitatepositioning of the device 10 in the patient's body. The proximal portion14 can also optionally be adjustably movable with respect to the distalportion 16 to allow the surgeon to adjust the angle and/or position ofthe proximal portion 14 with respect to the distal portion 16.

The handle 22 on the proximal portion 14 of elongate member 12 can alsohave a variety of configurations, shapes, and sizes. In an exemplaryembodiment, the handle 22 includes a gripping surface 24, such as aknurled surface, ridges, or grooves, to facilitate grasping of thedevice 10. In an alternative embodiment, or in addition to the handle22, the proximal portion 14 of the elongate member 12 can include aclamp member (not shown) formed thereon or mated thereto that iseffective to mate the device 10 to a surgical retractor, such as, forexample a Bookwalter retractor. Alternatively, the surgical retractorcan contain a post or surface for attaching to a Bookwalter having aclamp. A person skilled in the art will appreciate that a variety ofclamp members and/or other mating techniques can be used to mate thedevice 10 to a retractor or other type of support member.

The distal portion 16 of the elongate member 12 can also have a varietyof shapes and sizes, and it can mate to, or be integrally formed with,any portion of the guide member 30. In an exemplary embodiment, thedistal portion 16 has a generally elongate shape and includes front andback surfaces 16 a, 16 b that define a width W. While the width W canvary, the width W is preferably sufficient to retract tissue around theguide member 30 to provide access to the guide member 30 and thesurgical site. In an exemplary embodiment, at least a portion of thedistal portion 16 has a width W that is equal to or greater than a widthw of the guide member 30. The width W of the distal portion can alsooptionally increase in a proximal-to-distal direction. A person skilledin the art will appreciate that a back sidewall of the guide member 30can form part of the distal portion 16 of the elongate member 12, andthat the guide member 30 can be effective to retract tissue disposedtherearound.

The guide member 30, which is formed on, mated to, or integrally formedwith the distal portion 16 of the elongate member 12, can also have avariety of configurations, but it should include at least one pathwayformed therein for receiving a tool, such as, for example, an awl, adrill bit, a fastener, or a driver device. The pathway(s) is preferablyeffective to guide the tool to a spinal implant coupled thereto. In theembodiment illustrated in FIGS. 1-4, the guide member 30 includes twopathways 32 a, 32 b in the form of lumens extending therethrough. Thelumens 32 a, 32 b can be defined by or formed in two barrels and/oralternatively the lumens 32 a, 32 b can be formed in a housing. As shownin FIGS. 1-4, the lumens 32 a, 32 b extend through first and secondbarrels 33 a, 33 b that are mated to one another to form a substantiallyrectangular housing. The housing 30 generally includes opposed front andback sidewalls 31 a, 31 b, opposed lateral sidewalls 31 c, 31 dextending between the front and back sidewalls 31 a, 31 b, and proximaland distal ends 35, 37, as shown in FIGS. 2 and 3. The lumens 32 a, 32 bextend therethrough between the proximal and distal ends 35, 37 thereof.

Each lumen 32 a, 32 b in the guide member 30 can be positioned at anangle with respect to one another, as shown in FIG. 4. Moreparticularly, the longitudinal axes l₁, l₂ of each barrel 33 a, 33 b canbe positioned at an angle α₁, α₂ with respect to a longitudinal axis Lof the elongate member 12, such that the barrels 33 a, 33 b extend awayfrom one another in a distal-to-proximal direction. The angles α₁, α₂are determinative of the entry angle of a tool or device being insertedthrough the lumens 32 a, 32 b in each barrel 33 a, 33 b, and thus theangles α₁, α₂ should be set based on the intended use. The angles α₁, α₂of one or both barrels 33 a, 33 b can optionally be adjustable. Whilethe angles α₁, α₂ of the barrels 33 a, 33 b can vary, the barrels 33 a,33 b preferably lie in a plane that is substantially parallel to atleast a portion of a front surface 16 a of the distal portion 16 of theelongate member 12. This is particularly advantageous in that it onlyrequires a relatively small incision to be made in order to introducethe instrument into the surgical site, as the parallel guide member 30reduces the size of the instrument compared to a device in which theguide member 30 is positioned at an angle with respect to the elongatemember 12.

While not shown, the barrels 33 a, 33 b can be removably or fixedlymated to one another and/or to the guide member 30. For example, a baseplate (not shown) can extend between the distal end 37 of each barrel 33a, 33 b to mate the barrels 33 a, 33 b to one another and/or to theguide member 30. The base plate can include bores formed therein forremovably or fixedly receiving the barrels 33 a, 33 b. Removable barrels33 a, 33 b are particularly advantageous in that they allow barrelshaving different lengths to be selected based on the intended use.

FIGS. 5A and 5B illustrate another embodiment of a guide member 30′ foruse with the tissue retractor and guide device in accordance with thepresent invention. As shown, guide device 10′ is similar to guide device10, however the guide member 30′ is in the form of a substantiallyhollow housing having first and second pathways 32 a′, 32 b′ formedtherein and extending therethrough between proximal and distal ends 35′,37′ thereof. The housing 30′ includes opposed front and back sidewalls31 a′, 31 b′, and opposed lateral sidewalls 31 c′, 31 d′ extendingbetween the front and back sidewalls 31 a′, 31 b′. The proximal end 35′of the back sidewall 31 b′ is preferably mated to the distal portion 16′of the elongate member 12′, and more preferably the distal portion 12 b′of the elongate member 12′ is positioned at an angle with respect to theback sidewall 31 b′ of the guide member 30′. The back sidewall 31 b′ andthe elongate member 12′ can, however, optionally be integrally formedwith one another, or mated to one another, at any other location and inany configuration.

The pathways 32 a′, 32 b′ in guide member 30′ extend through the housing30′ and they are defined by the lateral sidewalls 31 c′, 31 d′ of thehousing 30′, in combination with the back sidewall 31 b′. In anexemplary embodiment, each lateral sidewall 31 c′, 31 d′ has asubstantially semi-cylindrical shape or is C-shaped. Accordingly, thesidewalls 33 a′, 33 b′ are substantially similar to barrels 33 a, 33 b,however, rather than having cylindrical lumens extending therethrough,they are at least partially open as a result of a cut-out portion 39′that extends therebetween, as will be discussed in more detail below.Each pathway 32 a′, 32 b′ is still configured to receive and guide atool toward a spinal fixation plate coupled to the guide member 21′.

A person skilled in the art will appreciate that the guide member, andeach pathway formed within the guide member, can have a variety of othershapes, sizes, and configurations as long as the pathway(s) is effectiveto guide a tool to a spinal implant.

Referring back to FIGS. 1-4, in another embodiment of the presentinvention, the guide member 30 can be adapted to rest against a spinalimplant, such as a spinal fixation plate, and more particularly theguide member 30 can include a distal end surface 37 having a shape thatis adapted to match the contour of a spinal fixation plate. By way ofnon-limiting example, as shown in FIGS. 1 and 4, the distal end 37 ofthe housing 30, i.e., barrels 33 a, 33 b, can have a substantiallyconcave shape that is adapted to rest against a spinal fixation platehaving a convex surface. The shape should, however, result in thealignment of the pathways in the guide member, i.e., lumens 32 a, 32 bin barrels 33 a, 33 b, with corresponding bores formed in a spinalfixation plate, as will be discussed below.

The device 10 can also other include features to facilitate placement ofthe device 10 at a surgical site, and more particularly that are adaptedto align the guide member 30 with a spinal implant and/or preventrotation between the guide member 30 and a spinal implant. In theembodiment illustrated in FIGS. 1-2 and 4, the elongate member 12 caninclude an extension portion 28 that is adapted to be positionedadjacent to a perimeter or edge of a spinal implant to provide a roughalignment between the device 10 and the spinal implant. The extensionportion 28 can be formed on a distal end 12 b of the elongate member 12and/or it can be formed on the guide member 30. It should, however,extend distally beyond the distal-most end of the guide member 30 toallow the extension portion 28 to rest against an edge of the implantwhile the guide member 30 is juxtapositioned on a surface of theimplant. As shown in FIGS. 1-2 and 4, the guide member 30 is attached tothe distal portion 16 of the elongate member 12 at a position that isjust proximal to the distal-most end 38 of the guide member 30, suchthat the distal-most portion of the elongate member 12 forms theextension portion 28.

In use, the front surface of extension portion 28 can abut the perimeteror edge of a spinal plate 80 to align the guide member 30 with the plate70. Accordingly, the front surface 29 of the extension portion 28 shouldhave a shape that matches the contour of at least a portion of theperimeter of an implant used therewith. In an exemplary embodiment, thefront surface 29 of the extension portion 28 is substantially planar torest against a planar surface on a spinal implant. In other embodiments,however, the front surface 29 of the extension portion 28 can have aconcave surface that is adapted to match the contour of an opposedconvex surface on the spinal plate, thereby further aligning the device10 with respect to the plate 80. The extension portion 28 can alsoinclude a distal-most end 40 that is adapted to rest against a vertebralbody, and more preferably the distal-most end 40 can have asubstantially concave shape to match the contour of a vertebra. A personskilled in the art will appreciate that the distal-most end 40 can havea variety of configurations, shapes and sizes, and it can be adapted torest against a vertebra and/or against a spinal fixation plate.

FIGS. 5A-5B illustrate another embodiment of an extension portion formedon guide member 30′. As shown, the guide member 30′ includes two tabs 28a′, 28 b′ that extend distally from the back sidewall 16 b′, 31 b′, andat least partially from the lateral sidewalls 31 c′, 31 d′, of the guidemember 30′. The tabs 28 a′, 28 b′ each preferably have a substantiallyconcave inner surface, as shown in FIG. 5A, such that they match thecontour of a substantially concave outer surface formed around opposedscrew bores formed in a spinal fixation plate. This allows the tabs 28a′, 28 b′ to rest against the perimeter or edge of the spinal fixationplate. The tabs 28 a′, 28 b′ can also optionally be adapted to providean interference fit with outer edges of the spinal fixation plate toengage the spinal fixation plate. By way of non-limiting example, thetabs can be formed on the opposed lateral sidewalls 31 c′, 31 d′ suchthat they can engage an implant therebetween. The tabs can alsooptionally be flexible or include other features to facilitateengagement of a spinal implant.

In another embodiment of the present invention, the tissue retractor andguide device can include one or more mating elements formed on a portionthereof to at least temporarily mate the device to a spinal implant,such as a spinal fixation plate. By way of non-limiting example, FIG. 4illustrates one embodiment of a mating element in the form of aprotrusion or pin member 42 that extends from a distal surface 38 of theguide member 30 at a location that is substantially between the firstand second barrels 33 a, 33 b. The pin member 42 is adapted to extendinto corresponding detents or bores formed in a spinal fixation plate,such as, for example, spinal plate 80 show in FIG. 6. The pin member 42can optionally extend at an angle to further facilitate grasping thespinal plate 80. In an exemplary embodiment, the mating element 42 isadapted to prevent rotation between the guide member 30 and the spinalplate 80 to provide stability to the connection. By way of non-limitingexample, mating elements with non-symmetrical shapes, such as a pin witha non-circular cross section (e.g. rectangular, oval, triangular,irregular), a multi-pronged mating element, or a tongue and groovecombination, can prevent or reduce the tendency of the device 10 topivot with respect to the spinal plate 80.

A person skilled in the art will appreciate that a variety of techniquescan be used to mate the device 10 to the spinal plate 80, and that themating element 42 can be formed on any portion of the device 10 and itcan be adapted to grasp any portion of the spinal plate 80. By way ofnon-limiting example, other suitable mating techniques include asnap-fit engagement, an interference fit, a spring clip, a threadedengagement, and any other mechanical connection.

In other embodiments of the present invention, the guide member 30, 30′can include one or more cut-out portions or windows formed therein tofacilitate visual access to a spinal fixation plate coupled thereto. Thecut-out portions can be formed anywhere in the housing 30, 30′, but inan exemplary embodiment, as shown in FIG. 5A, a cut-out portion 39′ isformed in a front sidewall 31 b′ of the housing 21′ between the firstand second pathways 32 a′, 32 b′, and it extends between the proximalend 35′ and distal end 37′ of the housing 30′. As a result, the pathways32 a′, 32 b′ are separated by the cut-out portion 39′. As previouslymentioned, the cut-out portion 29′ is particularly advantageous in thatit provides the surgeon with improved visual access to a spinal plateattached to the guide member 30′, as well as to the tools and devicesused in connection with the guide member 30′ and spinal fixation plate.

The guide member 30, 30′ can also optionally include a second, distalcut-out portion, such as cut-out portion 41′ shown in FIG. 5B, that isformed adjacent to the distal end 37′ of the housing 30′. This cut-outportion 41′ avoids interference by the guide member 30′ with a temporaryfixation pin that is disposed through the spinal fixation plate totemporarily attach the plate to bone. Since temporary fixation pins aretypically only placed on opposed ends of the plate, the distal cut-outportion 41′ is preferably only formed on a back side 31 a′ of the guidemember 21′, 23′.

In use, the device 10, 10′ is adapted to be juxtapositioned on a spinalfixation plate. Accordingly, by way of non-limiting example, FIGS. 6 and7 illustrate device 10 mated to an exemplary embodiment of a spinalfixation plate 80. In general, the spinal plate 80 includes a superiorand an inferior portion 81, 83, each having at least one bore 82 formedtherein for receiving a fixation device, e.g., a screw, to mate theplate 80 to a vertebra. The inferior and superior portions 81, 83 canoptionally be slidably movable with respect to one another such that theheight of the plate 80 is adjustable. In use, the plate 80 is adapted tospan across two vertebra such that the proximal portion 81 is mated toone vertebra and the distal portion 83 is mated to an adjacent vertebra.As indicated above, the device 10 can be mated to one of the inferior orsuperior portions 81, 83 of the spinal plate 80 by first positioning theextension portion 28 adjacent to a side on one of the inferior andsuperior portions 81, 83 of the spinal plate 80 to provide a roughalignment. The handle 22 on the elongate member can then be manipulatedto insert the mating element, e.g., pin 42, on the guide member 30 intothe corresponding receiving-bore (not shown) formed in the spinal plate80. In this configuration, the lumens 32 a, 32 b of guide member 30 arealigned with the bores 82 formed in the spinal plate 80.

With the distal portion of device 10 mated to and aligned with thespinal plate 80, the handle 22 can be used to retract tissue around theimplant site, and to position the plate against adjacent vertebrae. Thehandle can then either be held in position, or attached to an externalsupport structure, such as a Bookwalter, using a clamp disposed on thehandle or on the external support, to maintain the position of thespinal plate against the vertebrae.

When the plate is properly positioned against the spine and the tissueretractor and guide device 10 is aligned with the plate, a tool, such asa drill, awl, tap, or implant, can be passed through the each lumen 32a, 32 b in the guide member 30 to form a borehole in the vertebraeand/or to insert a spinal implant into the vertebrae.

In another embodiment, as shown in FIG. 8, two tissue retractor andguide devices can be mated to a single spinal plate 80 to retract tissuedisposed around the entire plate 80, and to allow a surgeon toefficiently prepare the vertebrae and implant the plate 80. As shown, afirst tissue retractor and guide device 10 a is mated to a inferiorportion 81 of the spinal plate 80, and a second tissue retractor andguide device 10 b is mated to the superior portion 83 of the spinalplate 80. Where the plate 80 has an adjustable height, as previouslydiscussed, the guide devices 10 a, 10 b are preferably used to fullyextend the plate 80. In order to maintain the position of the twodevices 10 a, 10 b with respect to one another, the present inventionalso provides a cross member 50 that is removably matable to the twodevices 10 a, 10 b. In an exemplary embodiment, two tissue retractor andguide devices 10 a, 10 b and a cross member 50 are provided in a kit.

The cross member 50 can have a variety of configurations, and in oneembodiment (not shown), it can include an elongate rod having opposedends. Each end is preferably adapted to removably mate to a tissueretractor and guide device 10 a, 10 b. In another embodiment, as shownin FIG. 7 the cross member 50 is in the form of a substantiallyrectangular-shaped housing that is adapted to fit around the elongatemember 12 a, 12 b of each device 10 a, 10 b. The rectangular shape ofthe cross member 50 is particularly advantageous in that it provides awindow to the surgical site, thereby allowing the surgeon to access theguide member 30 a, 30 b on each device 10 a, 10 b. A person skilled inthe art will appreciate that the cross member 50 can have virtually anyshape and size including, but not limited to, oval, rectangular,circular, and irregular.

The device can be formed from a variety of materials, including metals,such as stainless steel, and plastics. In an exemplary embodiment,however, the device, or at least a portion of the device, is formed froma radio lucent material to facilitate intraoperative imaging of thesurgical site. By way of non-limiting example, suitable radio lucentmaterials include carbon fiber, radel, or any other biocompatibleplastic or other material.

One of ordinary skill in the art will appreciate further features andadvantages of the invention based on the above-described embodiments.Accordingly, the invention is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims. All publications and references cited herein are expresslyincorporated herein by reference in their entirety.

1. A tissue retractor and guide device, comprising: an elongate memberhaving proximal and distal portions, the distal portion including asurface adapted to retract tissue; and a guide member coupled to thedistal portion of the elongate member and having first and secondpathways extending therethrough for receiving a tool, the pathwayshaving central longitudinal axes that are substantially parallel to atleast a portion of a front surface of the distal portion of the elongatemember, and having a cut-out portion extending between the first andsecond pathways, the guide member being adapted to be positioned inrelation to a spinal implant such that each of the pathways in the guidemember is aligned with at least one corresponding bore formed in thespinal implant to guide a tool through the bore and the cut-out portionprovides visual access to the spinal implant.
 2. The device of claim 1,wherein the guide member has a width that is equal to or less than awidth of at least a portion of the distal portion of the elongate membersuch that the distal portion of the elongate member is effective toretract tissue disposed adjacent to the guide member.
 3. The device ofclaim 1, wherein the guide member is adapted to be juxtapositioned onthe spinal implant.
 4. The device of claim 1, wherein the surface on thedistal portion of the elongate member is substantially planar.
 5. Thedevice of claim 1, wherein the guide member includes front and backopposed sidewalls, and opposed lateral sidewalls extending between thefront and back sidewalls, the back sidewall of the guide member beingcoupled to the elongate member.
 6. The device of claim 5, wherein thedistal portion of the elongate member is positioned at an angle withrespect to the back sidewall of the guide member.
 7. The device of claim5, wherein the opposed lateral sidewalls of the guide member aresubstantially C-shaped.
 8. The device of claim 5, further comprising atleast one extension portion extending distally from the guide member andadapted to align the first and second pathways in the guide member withcorresponding bores formed in a spinal implant.
 9. The device of claim8, wherein the at least one extension portion comprises first and secondtabs extending from the opposed lateral sidewalls of the guide member.10. The device of claim 9, wherein each tab has a substantially concaveinner surface that is adapted to be positioned against a substantiallyconcave outer surface formed on a perimeter of a spinal implant.
 11. Thedevice of claim 8, wherein the at least one extension portion extendsdistally from the back sidewall of the guide member.
 12. The device ofclaim 11, wherein the at least one extension portion is formed on thedistal portion of the elongate member and it extends a distance beyond adistal-most end of the guide member.
 13. The device of claim 11, whereina distal-most surface of the extension portion is substantially concaveto match the contour of a vertebral body.
 14. The device of claim 1,wherein the pathways are positioned at an angle with respect to oneanother.
 15. The device of claim 1, wherein the cut-out portion isformed in a front sidewall of the guide member between the two pathways.16. The device of claim 15, wherein the cut-out portion extends from theproximal end to the distal end of the guide member.
 17. The device ofclaim 1, wherein the proximal portion of the elongate member ispositioned at an angle with respect to the distal portion of theelongate member.
 18. The device of claim 17, wherein the angle is in therange of about 110° to 160°.
 19. The device of claim 1, wherein theproximal portion of the guide member includes a clamp member adapted tomate to an external support.
 20. The device of claim 1, wherein theproximal portion of the guide member includes a post adapted to attachto a clamp member on an external support.
 21. A tissue retractor andguide device, comprising: an elongate member having a proximal portionand a distal portion that is adapted to retract tissue; and a guidemember coupled to the distal portion of the elongate member and adaptedto be juxtapositioned on a spinal implant, the guide member including atleast one pathway extending therethrough for receiving a tool, and atleast one cut-out portion in a front sidewall of the guide memberadapted to provide visual access to the spinal implant, the at least onecut-out portion extending from a proximal end of the guide member to adistal end of the guide member, and the at least one pathway having acentral longitudinal axis that extends in a proximal-distal directionand that is substantially parallel to a plane containing the frontsidewall of the guide member, the plane of the front sidewall extendingin a proximal-distal direction.
 22. The device of claim 21, wherein theguide member includes front and back opposed sidewalls, and opposedlateral sidewalls extending between the front and back sidewalls, theback sidewall of the guide member being coupled to the elongate member.23. The device of claim 22, wherein the guide member includes twopathways extending therethrough.
 24. The device of claim 23, wherein thecut-out portion is formed in the front sidewall between the twopathways.
 25. The device of claim 22, wherein the opposed lateralsidewalls of the guide member are substantially C-shaped.
 26. A tissueretractor and guide kit, comprising: first and second tissue retractorand guide devices adapted to couple to a spinal implant, the first andsecond devices having a guide member having opposed front and backsidewalls, opposed lateral sidewalls extending between the front andback sidewalls, and first and second pathways formed therein forreceiving a tool, and an elongate member having a proximal, handleportion, and a distal, tissue-retracting portion coupled to the backsidewall of the guide member; and a cross member removably andreattachably connected to the first and second tissue retractor andguide devices.
 27. The kit of claim 26, wherein the cross membercomprises a substantially rectangular housing.
 28. The kit of claim 26,wherein the cross member comprises an elongate rod having opposed ends,each end being adapted to removably mate to a tissue retractor and guidedevice.
 29. A spinal fixation kit, comprising: a spinal fixation platehaving a superior portion with at least one bore formed therein forreceiving a fixation device effective to mate the superior portion to afirst vertebra, and an inferior portion with at least one bore formedtherein for receiving a fixation device effective to mate the inferiorportion to a second, adjacent vertebra; and at least one tissueretractor and guide device adapted to be juxtapositioned on the spinalfixation plate, the at least one tissue retractor and guide devicehaving a guide member having opposed front and back sidewalls, opposedlateral sidewalls extending between the front and back sidewalls, andfirst and second pathways formed therein for receiving a tool, at leasta portion of the first and second pathways being in communication withone another, and an elongate member having a proximal, handle portion,and a distal, tissue-retracting portion coupled to the back sidewall ofthe guide member; wherein the first and second pathways have centrallongitudinal axes that extend substantially parallel to at least aportion of the distal, tissue-retracting portion of the elongate memberand that do not intersect any portion of the elongate member, andwherein at least one of the first and second pathways in the guidemember is aligned with a bore formed in the spinal fixation plate whenthe guide member is juxtapositioned on the spinal fixation plate. 30.The kit of claim 29, wherein the first and second pathways are adaptedto be aligned with two adjacent bores formed in at least one of thesuperior portion and the inferior portion of the spinal fixation plate.31. The kit of claim 30, wherein the pathways are positioned at an anglewith respect to one another.
 32. The kit of claim 30, further comprisingat least one cut-out portion formed in the guide member and adapted toprovide visual access to a spinal implant coupled thereto.
 33. The kitof claim 30, further comprising first and second tabs extending distallyfrom a distal-most end of the guide member, the tabs being adapted toalign the pathways in the guide member with bores formed in the spinalfixation plate.
 34. The kit of claim 33, wherein the first and secondtabs extend from the back sidewall of the guide member.
 35. The kit ofclaim 33, wherein each tab has a substantially concave inner surfacethat is adapted to be positioned against a substantially concave outersurface formed on a perimeter of a spinal fixation plate.
 36. The kit ofclaim 33, wherein a distal-most surface of each tab is substantiallyconcave to match the contour of a vertebral body.
 37. The kit of claim29, wherein the guide member includes a cut-out portion formed in thefront sidewall between the first and second pathways.
 38. The kit ofclaim 37, wherein the cut-out portion extends between the proximal anddistal ends of the guide member.
 39. The kit of claim 37, wherein theopposed lateral sidewalls of the guide member are substantiallyC-shaped.
 40. The kit of claim 29, wherein a distal-most end of theelongate member extends a distance beyond a distal-most end of the guidemember to form an extension portion, the extension portion being adaptedto rest against a perimeter of the spinal fixation plate to align theguide member with the spinal fixation plate.
 41. The kit of claim 29,wherein a distal end of the guide member has at least one mating elementformed thereon and adapted to mate with a corresponding mating elementformed on the spinal fixation plate.
 42. The kit of claim 41, whereinthe at least one mating element has a shape that is adapted to preventrotation of the guide member with respect to the spinal fixation platewhen the guide member is positioned on the spinal fixation plate. 43.The kit of claim 29, wherein the superior and inferior portions of thespinal fixation plate are slidably movable with respect to each otherbetween a retracted position and an extended position.
 44. The kit ofclaim 43, further comprising a cross member effective to mate two tissueretractor guide devices to one another, and to maintain the spinalfixation plate in the extended position when the devices are mated tothe superior and inferior portions of the spinal fixation plate.